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Trial · Interventional

CompletedPhase 3Results postedRegistry data

TELESTAR (Telotristat Etiprate for Somatostatin Analogue Not Adequately Controlled Carcinoid Syndrome)

NCTNCT01677910 (opens ClinicalTrials.gov in a new tab)Other idLX1606.1-301-CSOther idLX1606.301Other id2012-003460-47
Open at ClinicalTrials.govAsk about this trial

This trial does not test a peptide that PepBank tracks.

  • Measures Lanreotide, does not give it. It appears in the eligibility rules.
  • Measures Octreotide, does not give it. It appears in the eligibility rules.

Overview

Status
Completed
Phase
Phase 3
Enrollment
135 participants (actual)
Sponsor
Lexicon Pharmaceuticals · Industry
Design
Randomized · Quadruple masking
Countries
12 countries

United States, Australia, Belgium, Canada, France, Germany, Israel, Italy, Netherlands, Spain, Sweden, United Kingdom

Start
8 Jan 2013
Primary completion
21 Mar 2016
Completion
21 Mar 2016
First posted
3 Sept 2012 (estimated)
Last update posted
27 Feb 2018
Conditions
Carcinoid Syndrome

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20132014201520162017
  1. Ph 3

    TELESTAR (Telotristat Etiprate for Somatostatin Analogue Not Adequately Controlled Carcinoid Syndrome)

    NCT01677910

    8 Jan 2013 to 21 Mar 2016

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The primary objective of the study is to confirm that at least 1 or more doses of telotristat etiprate compared to placebo is effective in reducing the number of daily bowel movements (BMs) from baseline averaged over the 12-week double-blind portion (Treatment Period) of the trial in patients not adequately controlled by current SSA therapy.

Interventions

  • Telotristat etiprateDrug
  • Placebo-matching telotristat etiprateDrug

Arms4

  • Experimental

    250 mg Telotristat Etiprate

    Following a 3 to 4-week run-in period on stable-dose somatostatin analog (SSA) therapy (octreotide or lanreotide) participants were randomized to receive one 250 mg telotristat etiprate tablet plus one placebo-matching telotristat etiprate tablet administered three times daily for 12 Weeks in the double-blind treatment period, followed by a 36 week open-label extension period.

  • Experimental

    500 mg Telotristat Etiprate

    Following a 3 to 4-week run-in period on stable-dose SSA therapy (octreotide or lanreotide) participants were randomized to receive, one telotristat etiprate 250 mg plus one placebo-matching telotristat etiprate tablet administered 3 times daily for 1 week, followed by two telotristat etiprate (250 mg) tablets administered three times daily for 11 weeks in the double-blind treatment period, followed by a 36 week open-label extension period.

  • Placebo comparator

    Placebo

    Following a 3 to 4-week run-in period on stable-dose SSA therapy (octreotide or lanreotide) participants were randomized to receive two placebo-matching telotristat etiprate tablets administered three times daily for 12 weeks in the double-blind treatment period, followed by a 36 week open-label extension period.

  • Experimental

    Telotristat Etiprate Open-Label Extension

    Patients previously assigned to 250 mg or 500 mg three times daily of telotristat etiprate were administered two 250 mg telotristat etiprate tablets three times daily in a 36 week open-label extension (OLE) period. Patients previously assigned to placebo were administered one 250 mg telotristat etiprate tablet plus one placebo-matching tablet three times daily for one week, followed by two 250 mg telotristat etiprate tablets three times daily for 35 weeks.

Primary outcomes3

Outcomes the sponsor listed as primary.

  1. Change From Baseline in the Number of Bowel Movements (BMs) Per Day Averaged Over 12 Weeks

    Time frame · Baseline and 12 Weeks

    Registry description

    Participants recorded the number of bowel movements per day in a daily diary. The total number of BMs per day were averaged over the 12-week period. A negative change from Baseline indicates improvement.

  2. Number of Participants With Treatment-Emergent Adverse Events (TEAEs) in the Double-Blind Treatment Period

    Time frame · First dose of study drug to within 30 days of last dose of study drug in the Double-Blind Treatment Period (Up to 17.6 Weeks)

    Registry description

    An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. A TEAE was an AE reported after the first dose of randomized treatment on Day 1.

  3. Number of Participants With TEAEs in the Open-Label Extension Period

    Time frame · First dose of study drug to within 30 days of last dose of study drug in the Open-Label Extension Period (Up to 54.3 Weeks)

    Registry description

    An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. A TEAE was an AE reported after the first dose of randomized treatment on Day 1.

Secondary outcomes(3)

  1. Change From Baseline in Urinary 5-hydroxyindoleacetic Acid (u5-HIAA) Levels

    Time frame · Baseline and Week 12

    Registry description

    u5-HIAA is a standard test used in clinical practice to assess neuroendocrine tumor (NET) activity and is collected as a 24-hour urine specimen. A negative change from Baseline indicates improvement.

  2. Change From Baseline in the Number of Daily Cutaneous Flushing Episodes Averaged Across All Time-Points

    Time frame · Baseline and 12 Weeks

    Registry description

    Participants recorded the number daily flushing episodes per day in a daily diary. The total number of flushing episodes per day were averaged over the 12-week period. A negative change from Baseline indicates improvement.

  3. Change From Baseline in Abdominal Pain Averaged Across All Time-Points

    Time frame · Baseline and 12 Weeks

    Registry description

    Participants recorded abdominal pain in a daily diary. Participants evaluated the level of any abdominal pain using an 11-point numeric rating scale, where: 0=no pain to 10=worst pain ever experienced. The average daily abdominal pain was averaged over the 12-week period. A negative change from Baseline indicates improvement.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· Baseline and 12 Weeks

Change From Baseline in the Number of Bowel Movements (BMs) Per Day Averaged Over 12 Weeks

GroupValue (counts/day)Spread
Placebo-0.6230.8275
250 mg Telotristat Etiprate-1.4331.3652
500 mg Telotristat Etiprate-1.4551.3098
Primary outcomeCount of participants· First dose of study drug to within 30 days of last dose of study drug in the Double-Blind Treatment Period (Up to 17.6 Weeks)

Number of Participants With Treatment-Emergent Adverse Events (TEAEs) in the Double-Blind Treatment Period

GroupValue (Participants)
Placebo39
250 mg Telotristat Etiprate37
500 mg Telotristat Etiprate42
Primary outcomeCount of participants· First dose of study drug to within 30 days of last dose of study drug in the Open-Label Extension Period (Up to 54.3 Weeks)

Number of Participants With TEAEs in the Open-Label Extension Period

GroupValue (Participants)
Telotristat Etiprate Open-Label Extension110
Secondary and other outcome results(3)
Secondary outcomeMean· Baseline and Week 12

Change From Baseline in Urinary 5-hydroxyindoleacetic Acid (u5-HIAA) Levels

GroupValue (mg/24 hours)Spread
Placebo11.35035.0346
250 mg Telotristat Etiprate-40.13484.7663
500 mg Telotristat Etiprate-57.51982.3273
Secondary outcomeMean· Baseline and 12 Weeks

Change From Baseline in the Number of Daily Cutaneous Flushing Episodes Averaged Across All Time-Points

GroupValue (counts/day)Spread
Placebo-0.1641.1572
250 mg Telotristat Etiprate-0.2961.3097
500 mg Telotristat Etiprate-0.5251.3413
Secondary outcomeMean· Baseline and 12 Weeks

Change From Baseline in Abdominal Pain Averaged Across All Time-Points

GroupValue (units on a scale)Spread
Placebo-0.2261.1601
250 mg Telotristat Etiprate-0.4891.4423
500 mg Telotristat Etiprate-0.3331.1784

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
PlaceboFollowing a 3 to 4-week run-in period on stable-dose SSA therapy (octreotide or lanreotide) participants were randomized to receive two placebo-matching telotristat etiprate tablets administered three times daily for 12 weeks in the double-blind treatment period.3 / 457 / 4539 / 45
250 mg Telotristat EtiprateFollowing a 3 to 4-week run-in period on stable-dose somatostatin analog (SSA) therapy (octreotide or lanreotide) participants were randomized to receive one 250 mg telotristat etiprate tablet plus one placebo-matching telotristat etiprate tablet administered three times daily for 12 Weeks in the double-blind treatment period.1 / 457 / 4537 / 45
500 mg Telotristat EtiprateFollowing a 3 to 4-week run-in period on stable-dose SSA therapy (octreotide or lanreotide) participants were randomized to receive, one 250 mg telotristat etiprate tablet plus one placebo-matching telotristat etiprate tablet administered 3 times daily for 1 week, followed by two 250 mg telotristat etiprate tablets administered three times daily for 11 weeks in the double-blind treatment period.1 / 458 / 4542 / 45
Telotristat Etiprate Open-Label ExtensionPatients previously assigned to 250 mg or 500 mg three times daily of telotristat etiprate were administered two 250 mg telotristat etiprate tablets three times daily in a 36 week open-label extension (OLE) period. Patients previously assigned to placebo were administered one 250 mg telotristat etiprate tablet plus one placebo-matching tablet three times daily for one week, followed by two 250 mg telotristat etiprate tablets three times daily for 35 weeks.9 / 11537 / 115110 / 115

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • DerivedSrirajaskanthan R, Pavel M, Kulke M, Clement D, Houchard A, Keeber L, Weickert MO. Weight Maintenance up to 48 Weeks in Patients With Carcinoid Syndrome Treated With Telotristat Ethyl: Pooled Data From the Open-Label Extensions of the Phase III Clinical Trials TELESTAR and TELECAST. Clin Ther. 2021 Oct;43(10):1779-1785. doi: 10.1016/j.clinthera.2021.08.014. Epub 2021 Sep 28. PMID 34598813
  • DerivedFust K, Maschio M, Kohli M, Singh S, Pritchard DM, Marteau F, Myrenfors P, Feuilly M. A Budget Impact Model of the Addition of Telotristat Ethyl Treatment to the Standard of Care in Patients with Uncontrolled Carcinoid Syndrome. Pharmacoeconomics. 2020 Jun;38(6):607-618. doi: 10.1007/s40273-020-00896-5. PMID 32157590
  • DerivedDillon JS, Kulke MH, Horsch D, Anthony LB, Warner RRP, Bergsland E, Welin S, O'Dorisio TM, Kunz PL, McKee C, Lapuerta P, Banks P, Pavel M. Time to Sustained Improvement in Bowel Movement Frequency with Telotristat Ethyl: Analyses of Phase III Studies in Carcinoid Syndrome. J Gastrointest Cancer. 2021 Mar;52(1):212-221. doi: 10.1007/s12029-020-00375-2. PMID 32146619
  • DerivedHudgens S, Ramage J, Kulke M, Bergsland E, Anthony L, Caplin M, Oberg K, Pavel M, Gable J, Banks P, Yang QM, Lapuerta P. Evaluation of meaningful change in bowel movement frequency for patients with carcinoid syndrome. J Patient Rep Outcomes. 2019 Oct 26;3(1):64. doi: 10.1186/s41687-019-0153-y. PMID 31655936
  • DerivedCella D, Beaumont JL, Hudgens S, Marteau F, Feuilly M, Houchard A, Lapuerta P, Ramage J, Pavel M, Horsch D, Kulke MH. Relationship Between Symptoms and Health-related Quality-of-life Benefits in Patients With Carcinoid Syndrome: Post Hoc Analyses From TELESTAR. Clin Ther. 2018 Dec;40(12):2006-2020.e2. doi: 10.1016/j.clinthera.2018.10.008. Epub 2018 Nov 24. PMID 30477789
  • DerivedWeickert MO, Kaltsas G, Horsch D, Lapuerta P, Pavel M, Valle JW, Caplin ME, Bergsland E, Kunz PL, Anthony LB, Grande E, Oberg K, Welin S, Lombard-Bohas C, Ramage JK, Kittur A, Yang QM, Kulke MH. Changes in Weight Associated With Telotristat Ethyl in the Treatment of Carcinoid Syndrome. Clin Ther. 2018 Jun;40(6):952-962.e2. doi: 10.1016/j.clinthera.2018.04.006. Epub 2018 May 1. PMID 29724499

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Histopathologically-confirmed, well-differentiated metastatic neuroendocrine tumor * Documented history of carcinoid syndrome and currently experiencing ≥4 bowel movements per day during the Run-in period * Currently receiving stable-dose somatostatin analog (SSA) therapy * Minimum dose of long-acting release (LAR) or depot SSA therapy * Octreotide LAR at 30 mg every 4 weeks * Lanreotide Depot at 120 mg every 4 weeks * Patients who cannot tolerate SSA therapy at a level indicated above will be allowed to enter at their highest tolerated dose * Ability and willingness to provide written informed consent Exclusion Criteria: * Presence of diarrhea attributed to any condition(s) other than carcinoid syndrome * Karnofsky Performance status ≤60% * Treatment with any tumor directed therapy, including interferon, chemotherapy, mechanistic target of rapamycin (mTOR) inhibitors \<4 weeks prior to Screening, or hepatic embolization, radiotherapy, radiolabelled SSA, and/or tumor debulking \<12 weeks prior to Screening * History of short bowel syndrome (SBS) * Clinically significant cardiac arrhythmia, bradycardia, tachycardia that would compromise patient safety or the outcome of the study * Previous exposure to telotristat etiprate

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